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Monoclonal Antibodies

Physicochemical Analysis

Harleen Kaur, Dietmar Reusch (Herausgeber)

Buch | Softcover

258 Seiten

2021
Academic Press Inc (Verlag)
978-0-12-822318-5 (ISBN)

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Monoclonal antibodies (mAbs) are naturally occurring complex biomolecules. New engineering methods have turned mAbs into a leading therapeutic modality for addressing immunotherapeutic challenges and led to the rise of mAbs as the dominant class of protein therapeutics. mAbs have already demonstrated a great potential in developing safe and reliable treatments for complex diseases and creating more affordable healthcare alternatives. Developing mAbs into well-characterized antibody therapeutics that meet regulatory expectations, however, is extremely challenging. Obstacles to overcome include the determination and development of physiochemical characteristics such as aggregation, fragmentation, charge variants, identity, carbohydrate structure, and higher-order structure (HOS).

This book dives deep into mAbs structure and the array of physiochemical testing and characterization methods that need to be developed and validated to establish a mAb as a therapeutic molecule. The main focus of this book is on physiochemical aspects, including the importance of establishing quality attributes such as glycosylation, primary sequence, purity, and HOS and elucidating the structure of new antibody formats by mass spectrometry. Each of the aforementioned quality attributes has been discussed in detail; this will help scientists in researching and developing biopharmaceuticals and biosimilars to find practical solutions to physicochemical testing and characterization.

Dr. Harleen Kaur research focuses on the development and characterization of large molecules, particularly monoclonal antibodies (mAbs) and bringing therapeutic molecules from early discovery and research stage to commercialization. Dr Kaur has previously worked for AstraZeneca and WuXi Biologics in the United States and has extensive experience in the development and testing of biologics as therapeutic molecules in a highly regulated environment. She earned her undergraduate degree from Guru Gobind Singh Indraprastha University, India, and PhD degree from the National University of Singapore, Singapore. Dr Kaur is the author of many peer-reviewed publications and book chapters in the area of antibody characterization and aptamers. She is also the lead editor of the book titled “Monoclonal Antibodies: Physicochemical Analysis that was published by Elsevier. Dietmar Reusch, PhD, is affiliated with Roche Diagnostics GmbH in Germany. His research focuses on the analytical development and characterization of large molecules, particularly mAbs, and on bringing therapeutic products from entry into human to commercial launch.

1. Overview of Monoclonal Antibodies
2. Physicochemical Characterisation of Monoclonal Antibodies
3. Glycosylation Analysis
4. The Use and Application of LC-MS-MS Petide Mapping Methodology for Primary Structure Confirmation, Sequence Variant Analysis and Comprehensive Analysis of Post-Translational Modifications
5. Separation Techniques for Characterization and Quantification of Antibody Purity
6. Higher Order Structure and Free Thiol
7. Advanced Structural Elucidation of New Antibody Formats by Mass Spectrometry

Erscheinungsdatum	16.08.2021
Zusatzinfo	50 illustrations (25 in full color); Illustrations
Verlagsort	San Diego
Sprache	englisch
Maße	152 x 229 mm
Gewicht	430 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
ISBN-10	0-12-822318-9 / 0128223189
ISBN-13	978-0-12-822318-5 / 9780128223185
Zustand	Neuware